The 6-Year Saga Finally Ends: FDA Issues Final Rule Modifying The Intended Use Regulation

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via A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply. It is embodied in parallel drug and device regulatory definitions of intended use (21 C.F.R. §§ 201.128 (drugs), 801.4 (devices)).

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